FDA approves blockbuster Eli Lilly drug for weight loss

The Food and Drug Administration (FDA) approved Eli Lilly’s blockbuster diabetes drug for weight loss management Wednesday, giving patients another tool and opening the door to potentially much wider use. 

Formal FDA approval means tirzepatide could be covered by most insurance plans, making it more affordable for millions of patients and likely adding to the massive demand for weight loss drugs like Wegovy and Ozempic.  

The agency approved Novo Nordisk’s Ozempic for diabetes and Wegovy for obesity in 2017 and 2021, respectively. Both drugs use the active ingredient semaglutide, but Wegovy to date had been the only approved drug on the market for obesity alone.  

Tirzepatide was previously approved to treat type 2 diabetes under the name Mounjaro. The drug will be marketed as Zepbound for chronic weight management in adults who have obesity or are overweight with at least one weight-related condition. 

Zepbound is a weekly injection that works by activating two naturally produced hormones in the body to reduce appetite and food intake.  

The drug is already widely prescribed off-label for weight loss in patients with obesity, but insurance companies may not cover it.  

“Obesity and overweight are serious conditions that can be associated with some of the leading causes of death such as heart disease, stroke and diabetes,” said John Sharretts, director of the FDA’s Division of Diabetes, Lipid Disorders, and Obesity, in a statement. “In light of increasing rates of both obesity and overweight in the United States, today’s approval addresses an unmet medical need.”  

Zepbound is expected to be available in the U.S. by the end of the year in six doses at a list price of $1,059.87 per month, Eli Lilly said. It’s a direct competitor to Wegovy, which costs about $1,300 per month.  

List price does not reflect the typical out-of-pocket cost to patients, and the company said it is putting a commercial savings card program in place. When the list price of a drug is higher, manufacturers can offer a bigger rebate for pharmacy benefit managers, which are supposed to pass savings on to patients. 

Aside from cost, weight loss drugs face other accessibility challenges. Private insurers have been unwilling to cover Wegovy and its sister medication Ozempic because they are viewed as lifestyle or cosmetic medicine and not essential. Ozempic is only approved as a diabetes treatment, though it’s prescribed off-label as an anti-obesity drug. Federal law bars Medicare from covering weight-loss drugs. 

“Far too many hurdles continue to prevent people living with obesity from accessing obesity treatments that could lead to significant weight loss,” Mike Mason, executive vice president and president of Lilly Diabetes and Obesity, said in a statement. “Broader access to these medicines is critical, which is why Lilly is committed to working with healthcare, government and industry partners to ensure people who may benefit from Zepbound can access it.” 

In a large clinical trial, patients without diabetes lost on average 18 percent of their body weight compared to those on a placebo when used in combination with a reduced-calorie diet and increased physical activity. 

About 70 percent of American adults have obesity or are overweight, and many of those overweight have a weight-related condition. Losing 5 percent to 10 percent of body weight through diet and exercise has been associated with a reduced risk of cardiovascular disease in adults with obesity or are overweight, the FDA said.